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U.S. Department of Health and Human Services

Product Classification
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Device calcium salt bone void filler, drillable, non-screw augmentation
Regulation Description Resorbable calcium salt bone void filler device.
Definition To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure. It is delivered to the defect and resorbs over time to be replaced by bone. Not for screw augmentation.
Physical State bone void filler and mixing and delivery system
Technical Method placed or injected in bony defects
Target Area various, specified bone voids (e.g., extremeties, pelvis)
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOIS
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3045
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Guidance Document
Third Party Review Not Third Party Eligible
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